The invention relates to a method for removing a fluid medium from a container, a removal device and a device for providing a fluid medium. Such methods and devices can, in particular, be used in the field of medicine, pharmacology or medical technology for removing and/or providing fluid media from/in a container under sterile or almost germ-free conditions, e.g. fluid media in the form of pharmaceuticals and/or diagnostic products. However, other fluid media may also be used. A particular focus of this disclosure relates to coupling a container containing a pharmaceutical and/or a diagnostic product to an injector for injecting the pharmaceutical and/or diagnostic product into body tissue of a user. However, other applications are also possible.
The prior art discloses a number of devices and methods that can be used to remove fluid media from a container. In many cases, it is of the utmost importance that the coupling is brought about under almost germ-free or even sterile conditions. Thus, for example, pharmaceuticals and/or diagnostic products, e.g. in liquid form, are filled into appropriate containers such as e.g. vials, cartridges, bottles, ampoules, carpules or similar containers under sterile-room conditions.
There often is the need to connect containers filled with the medium to further components under sterile conditions, particularly when applying parenteral medicines but also in the case of other liquid media, such as e.g. diagnostic products. An example of such a connection process that should be mentioned is the application of a sterile needle onto a cone (Luer cone) of a ready-made syringe, generally protected by a cap (tip cap), prior to an injection. The original integrity of the two systems, and hence their sterility, is broken for this brief coupling process. In the process, the risk of microbial contamination is very low, as exemplified by the large-scale use of this application, but it nevertheless still exists. The responsibility for a correct application generally falls to the user, e.g. a patient or a medical practitioner. The remaining risk of microbial contamination in such applications is generally already acceptable because the period of time between breaking the sterility, connecting the individual components and the application, e.g. the injection into a body tissue, is comparatively short and so, during this short period of time, there practically cannot be any growth of microbial contamination at the boundaries of the components to be interconnected.
However, in recent times there has been a noticeable trend to more complex injection systems. In particular, in the meantime, ready-made injection systems have been disclosed and become available, which, as auto-injectors, for example, are built for application by the patient himself or else by a medical practitioner. In the case of such ready-made injection systems, an injector is distributed together with a container filled with the fluid medium, e.g. the pharmaceutical and/or diagnostic product, for example in a packaged state. In the case of such ready-made injection systems, the responsibility for a safe coupling process between the filled container and the injector and/or another type of mechanical device shifts to the producer, and thus it must generally follow a validated production process. As a result of this trend to more complex injection systems there are additional production steps during production as a result of the last-mentioned requirement.
However, in practice it is hardly possible to satisfy these requirements. Thus, more complex injectors generally have a fluidic and/or mechanical system that, for example, comprises one or more needle elements. These may be held in an interior of the injector, which, in principle, can be manufactured under non-sterile conditions. This interior is subsequently closed off and disinfected or sterilized, for example by means of ionizing radiation. At the same time, or with a time offset, the associated container is generally filled and appropriately closed off under sterile-room conditions, for example by means of a septum and/or a stopper. A final assembly of the complex injector without interrupting the sterile-room conditions, i.e. connecting the complex mechanical part of the injector to the container while maintaining sterility, is generally very difficult to ensure for reasons of practicality. Accordingly, there will generally be a break in the sterility of the outer surfaces of the container and the mechanical part of the injector before these components are brought together to form the finished injector. However, the problem arises here that there must either be a further sterilization after bringing together the components—which is detrimental to the fluid media in many cases—or microbial growth must be accepted at the boundaries between the individual components over a number of months, namely while the finished injector is being stored. If the fluid medium is then removed through such a contaminated boundary, for example by this interface being pierced by a needle element, e.g. a cannula, this may lead to significant contamination of the fluid medium during the injection process.
This problem does not occur in the case of simple injectors without a relatively complex mechanical and/or fluidic system, like e.g. auto-injectors based on the principle of the syringe. In the case of such simple injectors, the problem is achieved by virtue of the fact that a sterile syringe, which already comprises an injection needle including a fluid connection, can be filled and/or closed in a single work step.
The prior art has also disclosed attachments for containers, the former containing a needle element and being able to be integrated into e.g. a flange cap of a stopper and/or septum. These attachments, which contain a comparatively simple mechanical system, are for example attached to the container under sterile conditions in a filling system. By way of example, the attachments are covered by a cap, which can later be pulled off during use such that a syringe can be connected to the attachment, by means of which the needle element can pierce into the interior of the container through the septum or through the stopper. Examples of such attachments are disclosed in International Publication No. WO 2006/027199 A1, in U.S. Pat. No. 6,258,078 B1, in U.S. Pat. No. 6,070,623, in U.S. Pat. No. 6,382,442 B1 or in U.S. Pat. No. 6,957,745 B2.
However, such attachments do not solve the above-described problem since these attachments generally have to be kept very simple in terms of their mechanics and therefore, for example, cannot contain relatively complex mechanical and/or fluidic elements such as e.g. pumps or the like because these have to be attached under sterile-room conditions. Moreover, the sterile surroundings are generally only terminated shortly before use.
WO 2005/002649 A1 has disclosed a medical device that can be placed onto a skin surface of a user and comprises a transcutaneous device that is provided under sterile conditions. It describes, inter alia, that a lever construction with a second needle section is held in a compressible sleeve, which lies loosely on an elastomeric septum of a medicine bag that can be penetrated by the needle section.
However, a disadvantage of the construction shown in WO 2005/002649 A1 is that the face of the sleeve and the septum merely lie loosely on one another. Hence, there may be ingress of contaminants, germs or moisture into the space between the sleeve and septum. Accordingly, WO 2005/002649 A1 explicitly describes that an external casing is additionally required after the disclosed device was assembled in order to keep said device in a clean state. This constitutes significant additional complexity and moreover does not provide protection against erroneous operations, for example as a result of a user opening the external casing prematurely and leaving it open for a relatively long period of time. Furthermore, there may be problems with condensation effects, particularly in the case of products that require chilled storage and temperature changes connected thereto, because e.g., even in an external casing, moisture is able to penetrate the space between the sleeve and the septum. Furthermore, as a result of the lever construction shown in WO 2005/002649 A1, the sleeve merely lies loosely on the septum. The bearing face and the weight of the lever, by means of which the sleeve is pressed against the septum, are thus strongly dependent on a positioning and alignment of the entire device. By way of example, if the device is rotated, the lever can move such that the sleeve is even removed from the septum and so there no longer is a bearing face. Hence, simple devices that provide at least largely safe and position-independent freedom from germs, even without complicated measures, would be desirable.